EDITORS' DESK

Novartis And The Arrival Of The Continuous Manufacturing Facility

The journey to implementation of the disruptive technology of continuous manufacturing began in 2005, according to Markus Krumme of Novartis, with a single question on a slide presented to Novartis development and manufacturing executives. “Why don’t we have facilities that can continuously produce materials?” then-CEO Daniel Vasella asked.

Three Experiences Power A Non-Profit’s Business Approach

Jennifer Dent is all business. At a nonprofit organization. She thinks that's exactly how it’s supposed to be. She also shares the enthusiasm of a humanitarian on a mission. Reviewing three experiences in the career of Dent, president of BIO Ventures for Global Health (BVGH), one might think none of this should be the case.

Vaccine Development Skating On Start-Ups

Ernst Soethout formed Virtuvax last year to take advantage of and further propel vaccine development trends, the most important being: “Big Pharma is ‘outsourcing’ R&D.” That in turn is driving the formation of virtual vaccine companies.”

Continuous Much More Than Manufacturing

Bernhardt Trout of the Novartis-MIT Center for Continuous Manufacturing, and Salvatore Mascia of CONTINUUS Pharmaceuticals, Inc., reveal the “true benefits” of this disruptive innovation. It’s not all about enabling new forms of manufacture, but also the discovery and development of novel molecular entities, and all the processes by which we will bring new drugs to patients.

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GUEST CONTRIBUTORS

  • Launching A New Drug In A Maturing Market — Lessons Learned From Recent COPD Entrants
    Launching A New Drug In A Maturing Market — Lessons Learned From Recent COPD Entrants

    Chronic obstructive pulmonary disease (COPD), a global growth market worth well over $15 billion in the U.S. and EU5 in 2016, has long represented a lucrative opportunity for drug manufacturers. However, the proliferation of treatments and increasing number of generics have begun to limit the potential for emerging therapies. A review of the successes and stumbles of the newest class of drugs (LABA/LAMA fixed-dose combinations) illustrates broader lessons manufacturers should consider when launching into a rapidly maturing market.

  • PDA Position Paper: A Call For Reform In Global Post-Approval Change Processes
    PDA Position Paper: A Call For Reform In Global Post-Approval Change Processes

    The seamless delivery of high quality, effective, and safe medicines to patients is each drug company’s ultimate duty. However, providing medication to patients is by no means effortless, as evidenced by the drug product shortage listings on health authority websites. The availability of medicines is challenged by a variety of factors, one of which is global supply chain segmentation due to global regulatory hurdles imposed on product related post-approval changes (PACs).

  • FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)
    FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)

    In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.

  • Troubleshooting Bacterial Contamination In Bioreactors
    Troubleshooting Bacterial Contamination In Bioreactors

    One of the most dreaded problems in large scale biomanufacturing is contamination events. These events negatively impact an organization in many ways: lost batches and production time, cost of investigations, cost of decontamination, compliance issues (if there is concern that the process is no longer in control), decreased product quality and patient safety, and lost revenues, depending on the root cause. I was personally involved in defending a recurring contamination investigation before FDA, where any delay in the approval of this blockbuster would have had a negative impact of tens of millions of dollars.

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PHARMA OUTSOURCING WHITE PAPERS

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ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Louis Garguilo Articles

INDUSTRY INSIGHTS

  • What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?
    What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?

    When a company is looking at acquiring or in-licensing a pharmaceutical product, there are a few technical factors that should be carefully considered before the deal is completed. 

  • Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies
    Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies

    There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago. 

    More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.  

  • Shift From Central Lab To POC
    Shift From Central Lab To POC

    As new technologies work to change the market space, this article takes a look at the market forces that are helping and hindering the shift to zero wait time for patient test results. Comprehensive analysis of both test settings allows for better understanding of the diagnostic landscape as it exists today, offering insight to both product and process innovations for your next generation product.

  • The Direct-To-Patient Model: Your Top 10 Q&A

    In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.

  • NEW DOCUMENT

    Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.

     

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OUTSOURCING EVENTS

Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success February 21, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Communication With FDA: What Do We Say And How Do We Say It? February 23, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Laboratory Data Integrity: Current Expectations for OOS Result Investigations February 24, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
The New Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown February 27, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
CRO Oversight: Risk Assessment & Action Planning March 1, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
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